Static devices and methods to shrink tissues for incontinence

ABSTRACT

The invention provides improved devices, methods, and systems for repeatably and reliably contracting fascia and other support tissues, particularly for the treatment of urinary incontinence. Rather than relying on a surgeon&#39;s ability to observe, direct, and control the selective shrinking of pelvic support tissues, a relatively large surface of a tissue contraction system is placed statically against the target tissue. Sufficient controlled energy is transmitted from the surface into the engaged tissue to contract the tissue and inhibit incontinence (or otherwise provide the desired therapeutic results).

This application is a continuation of, and claims the benefit ofpriority from, Provisional U.S. Patent Application Ser. No. 60/094,964,filed Jul. 31, 1998, the full disclosure of which is incorporated hereinby reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to medical devices, methods andsystems for selectively contracting tissues, particularly for thetreatment of urinary incontinence.

Urinary incontinence arises in both men and women with varying degreesof severity, and from different causes. In men, the condition mostfrequently occurs as a result of prostatectomies which result inmechanical damage to the urethral sphincter. In women, the conditiontypically arises after pregnancy when musculoskeletal damage hasoccurred as a result of inelastic stretching of the structures whichsupport the genitourinary tract. Specifically, pregnancy can result ininelastic stretching of the pelvic floor, the external sphincter, andthe tissue structures which support the bladder and bladder neck region.In each of these cases, urinary leakage typically occurs when apatient's abdominal pressure increases as a result of stress, e.g.,coughing, sneezing, laughing, exercise, or the like.

Treatment of urinary incontinence can take a variety of forms. Mostsimply, the patient can wear absorptive devices or clothing, which isoften sufficient for minor leakage events. Alternatively oradditionally, patients may undertake exercises intended to strengthenthe muscles in the pelvic region, or may attempt a behavior modificationintended to reduce the incidence of urinary leakage.

In cases where such non-interventional approaches are inadequate orunacceptable, the patient may undergo surgery to correct the problem. Awide variety of procedures have been developed to correct urinaryincontinence in women. Several of these procedures are specificallyintended to support the bladder neck region. For example, sutures,straps or other artificial structures are often looped around thebladder neck and affixed to the pelvis, the endopelvic fascia, theligaments which support the bladder, or the like. Other proceduresinvolve surgical injections of bulking agents, inflatable balloons, orother elements to mechanically support the bladder neck.

An alternative surgical procedure which is performed to enhance supportof the bladder is the Kelly plication. This involves midline plicationof the fascia, particularly for repair of central defects. In thistransvaginal procedure, the endopelvic fascia from either side of theurethra is approximated and attached together using silk or linensuture. A similar procedure, anterior colporrhaphy, involves exposingthe pubocervical fascia and reapproximating or plicating portions ofthis tissue from either side of the midline with absorbable sutures.While the Kelly plication and its variations are now often used forrepair of cystocele, this procedure was originally described for thetreatment of incontinence.

Each of these known procedures has associated shortcomings. Surgicaloperations which involve midline plications or direct suturing of thetissues of the urethra or bladder neck region require great skill andcare to achieve the proper level of artificial support. In other words,it is necessary to occlude or support the tissue sufficiently to inhibiturinary leakage, but not so much that intentional voiding is madedifficult or impossible. Balloons and other bulking agents which havebeen inserted can migrate or be absorbed by the body. The presence ofsuch foreign body inserts can also be a source of urinary tractinfections.

Alternative devices, systems, and methods for treatment of urinaryincontinence have recently been proposed in U.S. patent application Ser.No. 08/910,370, filed Aug. 13, 1997, and assigned to the assignee of thepresent invention. This reference, which is incorporated herein byreference, describes techniques for treating urinary incontinence byapplying sufficient energy to tissue structures that comprise or supportthe patient's urethra so as to cause partial shrinkage of the tissue,and thereby inhibit incontinence. Hence, these techniques generallyinvolve selectively contracting a patient's own pelvic support tissues,often applying gentle heating of the collagenated endopelvic structuresto cause them to contract without imposing significant injury on thesurrounding tissues. U.S. patent application Ser. No. 08/910,775, filedAug. 13, 1997, describes related non-invasive devices, methods andsystems for shrinking of tissues and is also incorporated herein byreference.

While these new methods for treatment of incontinence by selectivelycontracting tissues represent a significant advancement in the art,still further improvements would be desirable for treating urinaryincontinence in men and women. In particular, it would be desirable toprovide devices and therapies to reliably and repeatably contracttissues so as to effect the intended physiological change. It would bebest if these improved techniques and structures could provide reliableresults independent of the normal variations in the skill and experienceof the surgeon. It would further be desirable if these improvedtechniques could be performed using minimally invasive techniques so asto reduce patient trauma, while retaining and/or enhancing the overallefficacy of the procedure.

2. Description of the Background Art

The following U.S. patents and other publications may be relevant to thepresent invention: U.S. Pat. Nos. 4,453,536; 4,679,561; 4,765,331;4,802,479; 5,190,517; 5,281,217; 5,293,869; 5,314,465; 5,314,466;5,370,675; 5,423,811; 5,458,596; 5,496,312; 5,514,130; 5,536,267;5,569,242; 5,588,960; 5,697,882; 5,697,909; and P.C.T. PublishedApplication No. WO 97/20510.

SUMMARY OF THE INVENTION

The present invention provides improved devices, methods, and systemsfor repeatably and reliably contracting fascia and other supporttissues, particularly for the treatment of urinary incontinence. Thetechniques of the present invention generally enhance the supportprovided by the natural tissues of the pelvic floor. Rather than relyingentirely on the surgeon's ability to observe, direct, and control theselective shrinking of these tissues, the present invention makes use oftissue contraction systems which are placed statically against thetarget tissue, and which direct sufficient energy into the tissue so asto inhibit incontinence or the like.

In the preferred embodiment, a thin semi-rigid or rigid credit cardshaped device is inserted and urged flat against the endopelvic fascia.An array of electrodes is distributed across a treatment surface of thedevice, and the treatment surface will often be offset laterally fromthe urethra to avoid injury to the urinary sphincter or other delicatetissues. The treatment surface will often engage a relatively large areaof the endopelvic fascia, and will be held in a static position againstthis tissue while the electrodes are energized under computer control.The electrodes heat and shrink the engaged endopelvic fascia withminimal collateral damage to the surrounding fascia and tissues, whilethe device structure and controller will together generally avoidablation of the engaged endopelvic fascia.

Advantageously, sufficient shrinkage can be provided by the device inthe static position so that no additional heating/tissue contractiontreatments may be required to the endopelvic fascia on the engaged sideof the urethra. Hence, the present invention can take advantage ofautomated energy delivery circuits and/or selectable contraction probeshaving treatment surfaces of a variety of selectable sizes and shapes soas to predictably contract the target tissue, rather than relyingentirely on a surgeon's skill to contract the proper amount of tissue,for example, by manually "painting" a small electrode along the tissuesurface, and may also reduce fouling along the electrode/tissueinterface.

In a first aspect, the present invention provides a method for use in atherapy for inhibiting incontinence. The therapy effects a desiredcontraction of a discrete target region within an endopelvic supporttissue. The method comprises engaging a surface of a probe against thetarget region of the endopelvic support tissue. Energy is directed froman array of transmission elements disposed on the probe surface into thesupport tissue so as to effect the desired contraction of the targetregion. The energy directing step is performed without moving the probe.

The energy directing step will often comprise transmitting the energyacross a probe surface/tissue interface having a length of at least 10mm and a width of at least 5 mm. The energy will be sufficient tocontract the endopelvic support tissue with minimal damage to underlyingtissue. In the exemplary embodiment, the energy directing step comprisesapplying bipolar electrical energy between a plurality of electrodepairs.

In another aspect, the present invention provides a method for use in atherapy for incontinence. The incontinence therapy includes effecting adesired contraction of an endopelvic fascia. The endopelvic fascia iscomposed of a left portion and a right portion. The method comprisesaccessing a first target region along the left or right portion of theendopelvic fascia. The first target region is offset laterally from theurethra. A probe surface is positioned against the first target region,and energy is directed from the positioned probe surface into the firsttarget region so as to effect the desired contraction of the left orright portion of the endopelvic fascia. This energy is directed withoutmoving the positioned probe surface.

Generally, a second target region along the other portion of theendopelvic fascia will also be accessed. The second region is offsetlaterally from the urethra, so that the urethra is disposed between, andseparated from, the first and second target portions. Energy is directedfrom a probe surface into the second region so as to effect the desiredcontraction of the other portion without moving the probe surface. Theseenergy directing steps may optionally be performed simultaneously, ormay be performed sequentially by moving the probe from one side to theother. A protective zone of the probe surface can be aligned with theurethra to ensure that energy is not inadvertently transmitted from thetreatment surface to this delicate tissue structure. Such alignment maybe facilitated by introducing a catheter into the urethra.

In another aspect, the invention provides a method for selectivelycontracting a target tissue. The method comprises aligning a treatmentsurface of a probe with a first portion of the target tissue. Thetreatment surface has a peripheral portion and an interior portion.Energy is directed from the treatment surface into the first portion oftarget tissue so as to contract the first portion. Contraction of thefirst portion draws a second portion of the target tissue into alignmentwith the peripheral portion of the treatment surface. Energy can then beselectively directed from the peripheral portion of the treatmentsurface into the second portion of the target tissue. Advantageously,this allows tissue which was brought into alignment with the probeduring the beginning of the treatment to be heated and contracted as itis drawn under the electrodes without over-treatment of the previouslycontracted tissue.

In another aspect, the invention provides a device for effecting adesired contraction of a discrete target region of a tissue. The targetregion has a target region size and shape. The device comprises a probehaving a treatment surface with a size and shape corresponding to thesize and shape of the target region. At least one element is disposedalong the treatment surface for transmitting energy from the treatmentsurface to the target region without moving the probe such that theenergy effects the desired contraction.

In another aspect, the invention provides a device for effectingcontraction of a target fascial tissue. The target tissue has a fascialsurface. The device comprises a probe body having a treatment surface.The treatment surface is oriented for engaging the fascial surface, andhas a length of at least about 10 mm and a width of at least about 5 mm.The probe body is at least semi-rigid. An array of electrodes aredistributed over the target treatment surface for transmitting energyinto the engaged target tissue without moving the probe, such that theenergy contracts the target tissue.

In yet another aspect, the invention provides a device for contracting atarget tissue having a tissue surface. The device comprises a probehaving a treatment surface oriented for engaging the tissue surface ofthe target tissue. An electrode is disposed on the treatment surface ofthe probe, and is engageable against the target tissue surface so as tocontract the engaged target tissue from an initial size to a contractedsize. The electrode comprises a peripheral portion and an interiorportion. The interior portion has an area corresponding to thecontracted size of the tissue. The peripheral portion is energizeableindependently from the interior portion. This advantageous structureallows the tissue immediately surrounding the contracted tissue to beheated and contracted without overtreating (and imposing unnecessarytrauma) on the previously contracted tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a lateral cross-sectional view showing the urinary bladder anda bladder support structure.

FIG. 2 is a cross-sectional view of a patient suffering from urinarystress incontinence due to inelastic stretching of the endopelvicfascia.

FIG. 3 shows a known method for treating urinary incontinence byaffixing sutures around the bladder neck.

FIG. 4 illustrates improved bladder support provided by contracting theendopelvic fascia according to the principles of the present invention.

FIG. 5 is a perspective view of a probe having a thin flat credit cardshaped body and a treatment surface with a two-dimensional array ofbi-polar electrode pairs.

FIG. 5A is a front view of the probe of FIG. 5.

FIGS. 5B and C are side and front views, respectively, of a probe havingan electrode array supported by a shaft.

FIGS. 5D-G illustrate the structure and electrical layout of theelectrode array for the probe of FIGS. 5A and B.

FIGS. 6A-C are schematic block diagram showings of a static tissuecontraction system having an electrode array with optional temperaturefeedback signals.

FIGS. 7A-E schematically illustrate methods for accessing left and righttarget regions of the endopelvic fascia.

FIG. 8 is a cross-sectional view showing a method for treating a lefttarget region of the endopelvic fascia.

FIGS. 9A-D schematically illustrate a picture frame shaped tissuecontraction device having an independently energizeable peripheralportion so as to treat tissue surrounding an initially contractedregion.

FIGS. 10A and B illustrate an alternative probe having a two-dimensionalelectrode array.

FIGS. 11A and B illustrate a probe structure having a two-dimensionalarray of posts for independently engaging, heating and contractingtissue, in which the posts may optionally include resistive heaters andtemperature sensors.

FIG. 12 is a cross-sectional view of a probe structure having heattransfer surfaces thermally coupled to diodes and to the target tissueso as to allow the diodes to act as both heaters and temperaturesensors.

FIG. 12A is a drive/feedback block diagram for the probe of FIG. 12.

FIG. 13 illustrates an alternative probe structure in which a conduitdirects a heated fluid along a treatment surface of the probe.

FIG. 14 illustrates a still further alternative probe in which aplurality of irrigation ports are disposed between a one-dimensionalarray of elongate electrodes.

FIG. 15 illustrates a semi-rigid probe body which flexes to help ensurethe treatment surface of the probe is in contact with the target tissue.

FIG. 16 illustrates a probe having a cavity that receives the urethra tohelp ensure that the treatment surface is separated from the urethra bya protection zone.

FIGS. 17A-C illustrate front and side views of a probe having a balloonwhich urges the treatment surface of the probe against the targettissue.

FIGS. 18A-C illustrate a minimally invasive probe having interspersedheating and cooling areas to effect tissue contraction with minimaldamage to the target tissue, and in which the probe includes a balloonthat can be inserted to a treatment site in a narrow configuration andexpanded at the treatment site to engage and treat the full targetregion without moving the probe.

FIGS. 19A-C illustrate a probe having interspersed hot and cold posts.

FIG. 20 is a cross-sectional view showing a probe having a heatingelement with a limited quantity of a reaction material such that thetotal heat energy that will be transmitted to the target tissue islimited.

FIG. 21 illustrates a tissue contracting kit including the probe of FIG.5 and instructions for its use.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention generally provides methods, devices, and systemswhich repeatably contract tissue, particularly as a therapy forincontinence. The techniques of the invention will generally involvepositioning a probe so that a surface of the probe engages a targettissue statically, that is, without relative movement between the probeand the engaged tissue surface during treatment. Energy will then betransmitted from the treatment surface of the probe into the targettissue so as to effect the desired contraction. This allows thecontraction to be controlled by the configuration and/or software of thesystem, rather than relying on a surgeon's experience to allow him orher to "paint" a small area electrode surface across a sufficientportion of the target region at a proper rate to effect contractionwithout imposing excessive injury on the target tissue. As thesetechniques will be effective for controllably and repeatably contractinga wide variety of fascia and other collagenated tissues throughout thebody, they will find applications in a wide variety of therapies,including skin wrinkle shrinkage, tightening stretched tendons andligaments in knees, ankles, and wrists, treatment of droopy eyelids,shrinking large earlobes, and the like. However, the most immediateapplication for the invention will be to enhance the patient's ownnatural support of the bladder, bladder neck region, and urethra so asto inhibit urinary incontinence.

The techniques of the present invention will often be used to contractfascia, tendons, and other collagenous tissues, preferably withoutablation of these collagenous tissues. As used herein, this means thatcollagenous tissues are not removed and their function (particularlytheir structural support function) is not destroyed. Histologically,some tissue necrosis may occur, and the structural strength of thecontracted tissue may initially decrease after treatment. Nonetheless,the treated tissues will generally continue to provide at least somestructural support, and their structural strength should increase duringthe healing process so that the healed, contracted tissue has at leastalmost the same structural strength as, and preferably greaterstructural strength (for example, stretching less under tension) thanbefore treatment. Collagenous tissues may occasionally be referred toherein as collagenated tissues.

The pelvic support tissues which generally maintain the position of muchof the genitourinary tract, and particularly the position of urinarybladder B, are illustrated in FIG. 1. Of particular importance for themethod of the present invention, endopelvic fascia EF defines ahammock-like structure which extends laterally between the left andright arcus tendinous fascia pelvis ATFP. These later structures extendsubstantially between the anterior and posterior portions of the pelvis,so that the endopelvic fascia EF largely defines the pelvic floor.

The fascial tissue of the pelvic floor may comprise tissues referred tounder different names by surgeons of different disciplines, and possiblyeven by different practitioners within a specialty. In fact, somesurgeons may assign the collagenous support structure referred to hereinas the endopelvic fascia one name when viewed from a superior approach,and a different name when viewed from an inferior approach. Some or allof this support structure may comprise two collagenous layers with athin muscular layer therebetween, or may comprise a single collagenouslayer. In general terms, the therapy of the present invention may bedirected toward any of the collagenous portions of the supportstructures for the urethra, bladder neck, and bladder. Hence, thetreated tissues may include and/or be referred to as endopelvic fascia,arcus tendinous fascia pelvis, urethropelvic ligaments, periurethralfascia, levator fascia, vesicopelvic fascia, transversalis fascia,and/or vesicle fascia, as well as other collagenous support structures.

In women with urinary stress incontinence due to bladder neckhypermobility, the bladder has typically dropped between about 1.0 cmand 1.5 cm (or more) below its nominal position. This condition istypically due to weakening and/or stretching of the pelvic supporttissues, including the endopelvic fascia, the arcus tendinous fasciapelvis, and the surrounding ligaments and muscles, often as a result ofbearing children.

When a woman with urinary stress incontinence sneezes, coughs, laughs,or exercises, the abdominal pressure often increases momentarily. Suchpressure pulses force the bladder to descend still farther, shorteningor misaligning the urethra UR and momentarily opening the urinarysphincter.

As can be most clearly understood with reference to FIGS. 2-4, thepresent invention generally provides a therapy which effectively reducesthe length of the pelvic support tissues and returns bladder B towardsits nominal position. Advantageously, the bladder is still supported bythe fascia, muscles, ligaments, and tendons of the natural pelvicsupport tissues.

Referring now to FIG. 2, bladder B can be seen to have dropped from itsnominal position (shown in phantom by outline 10). While endopelvicfascia EF still supports bladder B to maintain continence when thepatient is at rest, a momentary pressure pulse P opens the bladder neckN resulting in a release of urine through urethra UR.

A known treatment for urinary stress incontinence relies on suture S tohold bladder neck N closed so as to prevent inadvertent voiding, as seenin FIG. 3. Suture S may be attached to bone anchors affixed to the pubicbone, ligaments higher in the pelvic region, or the like. In any case,loose sutures provide insufficient support of bladder neck N and fail toovercome urinary stress incontinence. Over tightening suture S may makenormal urination difficult and/or impossible.

As shown in FIG. 4, by reducing the effective length of the naturalpelvic support tissues, bladder B may be elevated from its loweredposition (shown by lowered outline 12). Alternatively, contraction ofselected tissues may reduce or eliminate slack in the support structureswithout raising the bladder, and/or may reduce the elongation of thesupport structures to reduce dropping of the bladder when under stress.A pressure pulse P will then be resisted in part by endopelvic fascia EFwhich supports the lower portion of the bladder, helping maintain thebladder neck in a closed configuration.

Fine tuning of the support provided by the endopelvic fascia is possiblethrough selective modification of the anterior portion of the endopelvicfascia. To close the bladder neck and raise bladder B upward, forexample, it may be possible to effect a greater total tissue contractiontowards the front. Alternatively, repositioning of bladder B to a moreforward position may be affected by selectively contracting the dorsalportion of the endopelvic fascia EF to a greater extent then the forwardportion. Hence, the therapy of the present invention may be tailored tothe particular weakening exhibited by a patient's pelvic supportstructures. Regardless, the portion of the endopelvic fascia EF adjacentthe bladder neck and urethra UR can remain free of sutures or otherartificial support structures which might directly compress the urethra.

Referring now to FIG. 5, a credit card shaped probe 20 includes a thinflat probe body 22 having a treatment surface 24. A two-dimensionalarray of electrodes 26 is distributed across treatment surface 24, theelectrodes here being arranged in bipolar pairs. Conductors 28, here inthe form of a plurality of insulated wires jacketed in a single bundle,extend from probe body 22 for coupling an electrical energy source toelectrodes 26.

As seen most clearly in FIG. 5A, treatment surface 24 of probe 20 has alength 29 and a width 30 that are significantly greater than a thicknessof probe body 22. Length 24 will typically be at least about 10 mm,while width 30 will generally be at least about 5 mm. Preferably, length28 will be between about 10 and 50 mm, with width 30 being between about5 and 30 mm.

Probe body 22 will usually have a thickness of between about 1 and 15mm. In many embodiments, the thickness of probe body 22 will be about 8mm or less, typically being from about 8 mm to about 1 mm, andpreferably being about 5 mm or less. The probe body will often be atleast semi-rigid. In other words, although probe body 22 may flex, theprobe body will generally have a stiffness greater than that of fascialtissue. This helps ensure that each of electrodes 26 can be effectivelycoupled to the fascial tissue surface by urging an interior portion ofthe probe body against the target tissue. Body 22 may flex slightlyduring such pressure so that both surfaces conform somewhat to eachother. Body 22 may be substantially rigid so that the fascial surfaceconforms substantially entirely to the shape of probe 20. The probe bodymay comprise a polymer such as polycarbonate, ABS plastic, or the like.

Where electrodes are used to heat the target tissue, the tissuetemperature can be controlled in a variety of ways so as to limitvariability in efficacy. Feedback to a computer which controls power toelectrodes 26 might directly indicate temperature, or the computer mightinstead control the treatment time. Signals might be provided to thecomputer indicating the electrical power being used, the electricalenergy which has been input to the tissue, or the impedance of thetissue as measured by the current and voltage of the RF energy deliveredto the probe. Additionally, the spacing between treated and non-treatedregions may be set by the structure of the probe and array, and/or byselectively energizing the electrodes of the probe. This furthercontrols the therapy to eliminate or reduce user variability.

Electrodes 26 may be substantially flush with tissue treatment surface24, or may alternatively protrude from the tissue treatment surface.When protruding electrodes are used, they will often present a roundedsurface for engagement against the fascial tissue so as to minimize theconcentration of electrical current density (as might otherwise occur atsharp corners). As is explained in more detail in U.S. patentapplication Ser. No. 08/910,370, filed Aug. 13, 1997, the fulldisclosure of which is incorporated herein by reference, the depth oftissue treatment may be varied when using bi-polar electrodes by settingthe spacing 32 between a pair of electrodes 34, and/or by setting adiameter or radius of curvature of electrodes 26 where they engage thetissue surface. In the exemplary embodiment, the electrodes have aradius of curvature of 0.012 inches, are formed of stainless steel, andare separated by about six times the radius of curvature (between theirinner edges) to limit heating depth to less than about 3 mm. The spacingbetween electrode pairs should allow treatment of a relatively largeamount of fascia without damage to the urethra. Spacing between pairsmay also leave some untreated tissue interspersed between the treatedregions, which will promote healing. The interspersed untreated areas ofthe target tissue may comprise fascia and/or other collagenous tissues,and the pairs may be separated such that at least a portion of theuntreated tissue can remain at or below a maximum safe tissuetemperature throughout treatment, optionally remaining below 60° C., andin some embodiments remaining below 45° C.

Using a bipolar credit card shaped configuration, a fascial tissue canbe safely heated to a contraction temperature by transmitting a currentbetween a pair of electrodes having a radius of curvature at the tissueinterface in a range from about 0.05 to about 2.0 mm, ideally beingabout 0.3 mm, where the electrodes are separated by a distance in therange from about 1 to about 10 times the radius of curvature of theelectrodes. This generally allows heating of the fascial tissue to adepth in the range between about 0.5 and 10 mm from the engaged tissuesurface, typically using an alternating current at a frequency atbetween about 100 kHz and 10 MHz with a voltage in a range of from about10 to about 100 volts rms (ideally being about 60 volts rms) and acurrent in a range from about 0.1 to about 10 rms amps. The drivingenergy may be applied using an intermittent duty cycle to effect thedesired increase in temperature. Generally, the tissue will be heated toa safe contraction temperature in a range from about 70° C. to about140° C. for a time in the range from about 0.5 to about 40 secs,typically for a time from about 0.5 to about 10 secs.

An alternative probe structure 20' is illustrated in FIGS. 5B and C. Inthis embodiment, probe body 22 is supported by a rigid shaft 23extending from a handle 25. Shaft 23 may be bent to orient treatmentsurface 24 to engage the endopelvic fascia. Optionally, a flex joint 27may be provided at the junction of shaft 23 and probe body 22 to helpensure that the entire treatment surface 24 engages the fascial surfacewhen the treatment surface is held in position manually from handle 25.Joint 27 may comprise a pliable or resilient structure and/or materialadjacent the shaft/body interface, such as an elastomer, a polymer, aball and socket arrangement, a pair of orthogonal pivots, or the like.Shaft 23 may comprise a stainless steel hypotube containing theconductors coupled to electrodes 26, or any of a variety of alternativemetal, polymer, or composite structures. The handle will often comprisea polymer such as polycarbonate, ABS plastic, or the like, and mayoptionally include controls for energizing the electrodes.

The configuration of the electrode array is generally fixed by the probebody structure. This often sets the tissue heating pattern (based on theelectrode size and spacing between electrode pairs), as the probe bodywill be held at a fixed position against the tissue during tissueheating. This predetermined heating pattern helps avoid over-treatmentof some tissues and under contraction of others, as can occur whenmanually painting a small treatment surface repeatedly across the targettissue.

It has been demonstrated that the shape and layout of the electrodes canprovide preferential contraction of the target tissue along a desiredorientation. Using the elongate electrodes 26 arranged in two series ofthree end-to-end pairs, and heating each pair of first one series, andthen the other series, sequentially (starting with the middle pair), theengaged tissue can be contracted to a significantly greater extent inwidth (across the electrode pairs) than in length (along theelectrodes). In fact, any pattern of elongate heated tissue zones (suchas between an elongate pair of electrodes) may provide preferentialcontraction across the elongate heat zones as compared to along theirlength, particularly when such elongate heat zones are alternated withelongate untreated zones (such as between the pairs). This can beextremely useful when a surgeon wants to, for example, decrease alateral width of the endopelvic fascia while minimizing the reduction inits anterior/posterior length.

Probe body 22 will often be formed as a multilayer structure tofacilitate electrically coupling conductors 28 to electrodes 26. Asshown in FIG. 5, for monopolar operation, only a single conductor needbe electrically coupled to the electrodes, while a separate conductorcan be coupled to a large return electrode placed on the leg or back ofthe patient. Bipolar operation will generally include at least two-conductors, while both monopolar and bipolar probes will often includelarger numbers of conductors to selectively vary the electrical poweracross treatment surface 24.

An exemplary structure for probe body 22 of probe 20' is illustrated inFIGS. 5D and E. Electrodes 26 are formed from wires of stainless steel,copper, or the like, but may alternatively comprise plates orientedperpendicularly to the treatment surface, the plates having rounded orradiused edges, with only the edges exposed. Electrodes 26 are coupledto the power supply with wires or other conductors disposed between amain probe body 22a and a back insulating layer 22b. The conductorsextend proximally through hypotube 23, which may also include a lumenfor delivering a conduction enhancing liquid or gel, typically fordelivery of about 1 cc/min of saline through one or more weep holes intreatment surface 24 adjacent or between the pairs of electrodes (as canbe understood with reference to FIG. 14). Probe body 22 will typicallybe rigid in this embodiment, often being formed of a polymer such as ABSplastic, polycarbonate, or the like, but may alternatively be semi-rigid(typically comprising silicone or nylon).

Probe 20 may optionally include a variety of mechanisms to activelycontrol contraction of the target tissue. Optionally, body 22 mayinclude multiplexing circuitry which selectively directs electricalenergy supplied through a limited number of conductors to the electrodesor electrode pairs. Such circuitry will optionally vary the electricalenergy or duty cycle of the electrodes depending on temperaturesmeasured at or near the electrodes. Alternatively, a uniform heatingenergy may be directed from treatment surface 24 based on one or moretemperature measurements, based on dosimetry, or the like. Circuitry forprobe 20 may incorporate microprocessors or the like. Alternatively,signals may be transmitted from the probe to an external processor forcontrol of the contraction energy.

Exemplary probe circuits are illustrated in FIGS. 5F and G. The couplingarrangement illustrated in FIG. 5F allows an M×N array of electrodepairs to be selectably energized using only M+N conductors. Thisarrangement takes advantage of the fact that current (and heating) willbe concentrated along the path of least electrical resistance, whichwill generally be between the two closest bipolar electrodes. In thiscase, rows of electrodes are coupled together and columns of electrodesare coupled together so that a particular electrode pair 1, 2, 3, . . .6 is selected by driving a current between the associated column and theassociated row. For example, electrode pair 3 is selected by drivingbipolar current between the electrodes of column 1 and the electrodes ofrow 2. Current (and heating) between energized electrodes other thanpair 3 will not be sufficient to significantly contract tissue. In theexemplary embodiment, the electrode pairs are energized by heating eachpair associated with a column starting with the middle pair (forexample, pair 3, then pair 1, then pair 5), and then moving on to thenext column (for example, pair 4, pair 2, and then pair 6).

The probe circuit of FIG. 5G allows the electrode pairs to beselectively energized, and further provides calibrated temperatureinformation from adjacent each electrode pair (temperatures may bemonitored selectively, for example, at the active electrode only).Temperature sensors 31 may comprise thermistors, thermocouples, or thelike, and will be mounted to probe body 22 so as to engage the tissuebetween a pair of electrodes to limit the number of signal wires,temperature sensors 31 are coupled to a multiplexer MUX mounted inhandle 25, or possibly in probe body 22. As such temperature sensorsprovide temperature signals which are repeatable (for each mountedsensor) though not necessarily predictable, the accuracy of thetemperature feedback can be enhanced by storing calibration data forthis probe, and ideally for each temperature sensor, in a non-volatilememory such as an EEPROM.

Static contraction systems including probe 20 are shown schematically inFIGS. 6A-C. In general, power from an electrical power source 33 isdirected to the electrodes of probe 20' by a switching unit 35 under thedirection of a processor 37. These functions may be combined in avariety of arrangements, such as by including the processor and theswitching unit, some or all of the switching unit circuitry with theprobe, or the like. Where temperature feedback is provided, such as inthe system of FIG. 6C, the temperature may be controlled by selectivelyenergizing and halting power to the probe (sometimes called a bang-bangfeedback control) to maintain the desired temperature or temperatureprofile, or the controller and/or switching unit may selectively varythe power level.

Advantageously, the total desired shrinkage of a discrete target regionof endopelvic fascia EF may be controlled without moving probe 20. Totalcontraction of the endopelvic fascia will depend on a number of factors.Generally, tissue will contract locally by up to 70% (areal shrinkage)when heated to contraction temperature range. Therefore, it is possibleto select a probe 20 having a treatment surface 24 with a size and shapesuitable for providing a total effective contraction of endopelvicfascia EF so as to provide the desired improvement in support of thepelvic floor. It may therefore be desirable to provide a series ofdiffering probes for contracting tissues by differing amounts. Forexample, it may be possible to select a probe having a lateral dimensionof 12 mm to decrease an effective lateral dimension of the right portionof the endopelvic fascia by 5 mm. A greater amount of contraction mightbe effected by selecting an alternate probe with a greater width.Selecting probes having differing lengths, selecting among alternativeprobes having treatment surfaces 24 which are wider at one end than theother, or selectively positioning the probe along the midline mightallow the surgeon to tailor the enhanced support to lift the anterior orposterior portions of the bladder to a greater or lesser degree, asdesired.

Still further alternative contraction control mechanisms might be used.Rather than selecting alternative probes, it may be possible to vary theheating energy among the electrodes. Where a lesser degree ofcontraction is desired, the surgeon may heat the tissue to a lowertemperature, and/or may selectively heat only a portion of the tissuewhich engages treatment surface 24 (for example, by energizing only aselected subset of electrodes 26). Electrical properties of the systemcan be monitored before, during, between, and/or after energizing theprobe with tissue heating current. For example, as the controllerselectively energizes the electrode pairs, the system impedance can bemonitored to help ensure that sufficient electrode/tissue coupling ismaintained for the desired treatment. In a simple feedback indicationarrangement, a warning light may illuminate to inform the surgeon thatcoupling was (or is) insufficient. More sophisticated feedback systemsmay re-treat selected undertreated areas by re-energizing electrodepairs for which coupling was compromised. Generally, these feedbacksystems generate a feedback signal FS to indicate an effect of thetreatment on the tissue, as schematically illustrated in FIG. 6A.Feedback signal FS may simply provide an indication to the surgeon, ormay be processed by the controller to modify the treatment. Regardless,this controlled contraction can be provided without moving probe 20.

Methods for accessing target regions of the endopelvic fascia areillustrated in FIGS. 7A-E. In general, endopelvic fascia EF can beviewed as left and right fascial portions separated at the patient'smidline by urethra UR. Endopelvic fascia EF is supported by ligamentsATFP above a vaginal wall VW. It may be desirable to selectively shrinkendopelvic fascia EF along target regions 40 which extend in an anteriorposterior direction along the left and right sides of the endopelvicfascia. This should provide enhanced support of urethra UR, the bladderneck, and the bladder with little risk of heating, denervating orinjuring the delicate urethral tissues.

To access target regions 40 with minimal trauma to the patient, aweighted speculum 42 is inserted into the vagina to expose the anteriorvaginal wall VW. Optionally, elongated laterally offset incisions 43might be made in the anterior vaginal wall so that the vaginal mucosacould be manually dissected to reveal the endopelvic fascia EF. However,to minimize trauma and speed healing, a small incision 44 may be made oneither side of urethra UR, thereby allowing access for a minimallyinvasive blunt dissection device 46. Dissection device 46 includes amechanical expansion element in the form of a balloon 48 at its distalend. Balloon 48 dissects the back side of the vaginal wall from theendopelvic fascia to create a minimally invasive treatment site 50 alongeach of the discrete target regions 40, as seen in FIG. 7D. Regardlessof the specific access technique, the exposed endopelvic fascia willpreferably be irrigated with saline or the like to reduce fouling of theelectrodes, and to enhance electrode/tissue coupling with a conductivefilm. The patient will preferably be positioned so that excessirrigation fluid drains from the tissue surface, and aspiration willoften be provided to clear any drained fluids.

An alternative method for accessing the endopelvic fascia is illustratedin FIG. 7E. This is sometimes referred to as the Raz technique, andgenerally comprises separating an arch-shaped mid-line flap F from thesurrounding vaginal wall VW to access the underlying and adjacentendopelvic fascia as shown. This procedure was described in more detailby Shlomo Raz in Female Urology, 2nd. Ed. (1996) on pages 395-397.

Referring now to FIG. 8, probe 20 is inserted through incisions 43 or 44to treatment site 50. Treatment surface 24 is urged against exposedsurface 52 of endopelvic fascia EF so that electrodes 26 are effectivelycoupled with the endopelvic fascia. Probe 20 may be biased against theendopelvic fascia manually by pressing against the wall of vaginalmucosa VM, by pressing directly against the probe using a fingerinserted through incision 43 or 44, or using a shaft attached to theprobe that extends proximally through the incision. Alternatively, aswill be described hereinbelow, probe 20 may include a mechanicalexpansion mechanism for urging treatment surface 24 against theendopelvic fascia EF.

Once the probe engages target region 40 of endopelvic fascia EF,electrodes 26 are energized via conductors 28 (see FIG. 5). Electrodes26 direct electrical current through the endopelvic fascia so that theresistance of the fascia causes an increase in tissue temperature. Theuse of relatively large electrode surfaces having a sufficiently largeradius of curvature avoids excessive concentration of electrical currentdensity near the tissue/electrode interface which might cause charring,tissue ablation, or excessive injury to the tissue.

As endopelvic fascia EF is heated by probe 20, the collagenated tissueswithin the fascia contract, drawing the tissue inward along treatmentsurface 24. Although probe 20 does not move during this contraction, itshould be noted that at least a portion of endopelvic fascia EF mayslide along treatment surface 24, since the tissue contracts while theprobe generally does not.

As can be understood with reference to FIGS. 9A-D, the probes of thepresent invention can effectively treat a larger region of the targettissue than is initially engaged by the treatment surface. FIG. 9Aschematically illustrates a treatment surface 24 having a peripheral"picture frame" portion 56 which can be energized independently of aninterior portion 54. By energizing both portions 54 and 56, tissue 58engaging treatment surface 24 contracts inward as shown in FIG. 9B. Oncethis first stage of tissue has been contracted, however, additionalheating of the contracted tissue will generally not provide contractionto the same degree, but may impose additional injury. Therefore,peripheral portion 56 can be energized independently of the interiorportion so that the uncontracted tissue 60 that now engages treatmentsurface 24 can be safely contracted.

While interior portions 54 and peripheral portion 56 are illustrated ascontiguous treatment zones, it should be understood that they mayactually comprise independently energizeable arrays of electrodes.Additionally, it should be understood that peripheral portion 56 neednot completely surround interior portion 54, particularly where theprobe includes some structure that affixes a portion of the proberelative to the engaged tissue.

A wide variety of alternative electrode array structures might be used.As illustrated in FIG. 10A, electrodes 62 may optionally comprisemonopolar or bipolar rounded buttons or flat disks defining atwo-dimensional array. In some embodiments, a temperature sensor may beprovided for each button. For bipolar heating, radiofrequency currentmay be driven from one button electrode to another. Alternatively,radiofrequency current may be driven from each button to a large surfacearea pad applied against the patient's back in a monopolarconfiguration.

When used in a bipolar mode, it may be desirable to drive radiofrequencycurrent between pairs of electrodes that are separated by at least oneother electrode. This may allow heating to a more even depth, as heatingenergy will be concentrated near the engaged tissue surface adjacenteach electrode, but will be distributed to a greater depth midwaybetween the electrodes of a bipolar pair. For example, it is possible todrive radiofrequency current from electrode 62a to electrode 62c, fromelectrode 62b to electrode 62d, from electrode 62e to electrode 62g,from electrode 62f to electrode 62h, and the like.

Advantageously, in an N×M electrode array, it is possible toindependently drive each of these electrode pairs using only N+Mconductors between the driving power source and the electrodes, asdescribed above regarding FIG. 5F.

A wide variety of alternative electrode and probe structures may beused. For example, the button electrodes of FIGS. 10A and B may bemounted on an inflatable balloon which could be rolled up into a narrowconfiguration for insertion to the treatment site. The balloon couldthen be inflated to allow engagement of the treatment surface againstthe target tissue.

A still further alternative probe structure is illustrated in FIGS. 11Aand B. In this embodiment, a two-dimensional array of protrusions 64each include a resistive heater 66 and a temperature sensor 68. As heattransfer between the probe and the tissue is by conduction of heatrather than by conduction of electrical current, the ends of protrusions64 can safely include corners without concentrating heat. Hence, theprotrusions can have heat transfer ends that are round, square,hexagonal, or the like, and the protrusions can be cylindrical, conical,or some other desired shape. Alternatively, flush heat transfer surfacesmay be formed with similar structures.

Preferably, the protrusions 64 can be pressed against the tissue surfaceand resistive heaters 66 can be energized while active temperaturefeedback is provided by temperature sensor 68. This feedback can be usedto heat the protrusions to the desired treatment temperature for apredetermined time so as to effect the desired tissue contraction.Alternatively, the temperature sensors may measure the actualtemperature of the tissue, rather than that of the protrusion.

Referring now to FIG. 12, a two-dimensional array of heat transfersurfaces 70 might make use of thermally conductive materials that extendfrom or are flush with treatment surface 24. At least one electricalcomponent 72 is thermally coupled to an associated heat transfer surface70 so that the component varies in temperature with the temperature ofthe surface. The component will typically have an electricalcharacteristic which varies with temperature, the component typicallycomprising a transistor, thermistor, or silicon diode. Component 72 canbe coupled to conductor 28 using a printed circuit board 74.

Electrical current is driven through component 72 so that the componentheats heat transfer surface 70. The tissue engaging heat transfersurface 24 is heated by passive conduction from heat transfer surfaces70. Preferably, the heating electrical current is applied asintermittent pulses. Between heating pulses, a small constant currentcan be driven through a diode in a forward direction, and the voltageacross the junction can be measured using printed circuit board 74. Theforward voltage across this junction is often dependent on thetemperature of the junction, typically varying by about 2 mV/° C. for asilicon diode. This forward voltage can be used to measure the junctiontemperature. The timing of the heating pulses and the structure of heattransfer surface 70 can be set so that the diode junction will indicatethe temperature of the tissue against which the heat transfer surface isengaged, with the diode junction preferably being at or near anequilibrium temperature during a slow gradual heat cycle.

The temperature indication signal provided by the low-power, betweenheating pulse can be used as a feedback control signal. The arrayideally comprises a two-dimensional array, and feedback signals frommultiple heat transfer surfaces of the array should allow very goodcontrol of the local tissue contraction temperature throughout thetreatment surface/tissue interface. Such an array of transistors ordiodes coupled to a power source via conductor 28 and printed circuitboard 74 provides a very inexpensive way to selectively control thetemperature across treatment surface 24.

FIG. 12A is an exemplary circuit including the probe of FIG. 12. A largevariable current I₁ is sufficient to heat diodes 72 so as to treat theengaged tissue, preferably under proportional control. A small constantcurrent I₂ does not significantly heat the engaged tissue, but doesallow measurement of the forward voltage drop across each diode.Applying a constant small current I₂, the voltage drop across a diode 72thermally coupled (through a metal plate) to the tissue will be about0.7 v-2 mV/° C. for a silicon diode so as to indicate the tissuetemperature. Once again an EEPROM or other non-volatile memory may storecalibration data for each diode, ideally storing calibration constantsfor at least two temperatures from calibration tests conducted prior todelivery and/or use of the probe.

As illustrated in FIGS. 13 and 14, still further alternative heatingmechanisms might be used. In FIG. 13, a conduit 76 directs a relativelyhigh temperature fluid along a serpentine path adjacent treatmentsurface 74, the heated fluid typically comprising steam or the like. Inthe embodiment of FIG. 14, a one dimensional array of elongateelectrodes 80 is distributed across treatment surface 24, withirrigation ports 82 being disposed between and/or around the electrodes.

When accessing the endopelvic fascia transvaginally, the midline neednot be dissected, as described above. This minimizes the possibility ofinadvertently treating and/or injuring the urethra. Generally, treatmentcan be made symmetric by statically positioning the probe against thetarget region on the left side of the endopelvic fascia, and staticallypositioning the same or a different probe on the right side of theendopelvic fascia without accessing the fascia adjacent the urethra.Alternatively, it may be possible to treat only one side and effectivelyinhibit incontinence, particularly where only one side of the endopelvicfascia has an excessive length. Nonetheless, it may be desirable toaccess the endopelvic fascia across the midline, particularly whentreating both the left and right target regions simultaneously with asingle probe.

The use of a semi-rigid probe body 22 can be understood with referenceto FIG. 15. Probe 20 flexes when held against endopelvic fascia EF by aforce F to ensure engagement between treatment surface 24 and theendopelvic fascia throughout the desired interface region. Optionally,probe body 22 may be pre-curved to facilitate coupling between thetreatment surface and the target tissue. For example, a thin flat probebody which is slightly convex might be held against the target tissue bypressure F2 at the edges of the treatment surface (rather than a centralpressure F) until the device becomes substantially flat, therebyindicating to the surgeon that the proper amount of tissue engagingpressure is being applied.

FIG. 16 illustrates a structure and method for aligning probe body 22along the endopelvic fascia so that treatment region 40 is separatedfrom the urethra by a protection zone 86. A catheter 88 is introducedinto the urethra, which facilitates identification of the urethra alongthe endopelvic fascia. Optionally, cooled water may be circulatedthrough the catheter to avoid any injury to the urethra duringtreatment. It should be understood that such a urethral cooling systemmay be desirable for many embodiments of the present systems andmethods.

To facilitate aligning treatment surface 24 with target region 40,urethra UR is received in a cavity 88 of probe body 22. Cavity 88 isseparated from treatment surface 24 by a desired protection zone 86. Asa method for using this probe will generally involve dissecting themucosa from the endopelvic fascia so as to access the fascia nearurethra UR, the probe body may extend bilaterally on both sides of theurethra to simultaneously treat the left and right portions of theendopelvic fascia, as is indicated by the dashed outline 90. Such abilateral system can avoid injury to the urethral tissues by heating two(left and right) discrete treatment regions separated by a protectionzone. Bilateral systems might evenly treat the two sides of theendopelvic fascia by sequentially energizing two separated arrays ofelectrodes in a mirror-image sequence, the two sides being treatedsimultaneously, sequentially, or in an alternating arrangement.

Referring now to FIGS. 17A-C, the static tissue contraction probes ofthe present invention may optionally include an expansion mechanism suchas balloon 92 to urge treatment surface 24 against the target tissue.The device might again be inserted through incisions into the anteriorvaginal wall on either side of the urethra. Electrodes 26 are againmounted on a probe body 22 which is at least semi-rigid, with aresilient balloon 92 molded to the back of the probe body. The ballooncan be inflated after the probe is positioned to urge treatment surface24 against the target tissue with a repeatable electrode/fasciainterface pressure.

Balloon 92 will preferably comprise an elastomer such as silicone or thelike.

To improve coupling between the electrodes and the target tissue,defibrillator gel or saline may be provided at the treatmentsurface/tissue interface. These enhanced coupling materials may beplaced on the probe or tissue surface prior to engagement therebetween,or may alternatively be delivered through ports adjacent the electrodes.

FIGS. 18A-C illustrate a still further alternative probe structure. Inthis embodiment, an expandable probe 94 is inserted through a smallincision while the probe is in a narrow configuration. Once the probe ispositioned adjacent the target tissue, balloon 96 is inflated via aninflation lumen 98. The balloon expands against an opposing tissue so asto urge treatment surface 24 against the endopelvic fascia.

Once inflated, fluid is passed through conduits adjacent the treatmentsurface to thermally treat the endopelvic fascia. In this embodiment, ahot fluid conduit 100 is arranged in a serpentine pattern whichalternates with a cold fluid conduit 102 so that the treatment surfacecomprises interspersed zones of heating and cooling. Heating tissues toa safe contraction temperature between cooled zones will inducecontraction with less injury to the tissue than would otherwise beimposed, as the regions of heated tissue are interspersed with, andprotected by, the tissue cooling.

Still further alternative treatment mechanisms are illustrated in FIGS.19A-C, and in FIG. 20. In the embodiment of FIGS. 19, tissue heating andcooling are interspersed using a device which includes a heated plate104 having a series of 30 heated protrusions 106 in combination with acooled plate 108 having interspersed cooled protrusions 110 and passages112. Passages 112 receive heated protrusions 106, while a thermallyinsulating material 114 insulates the plates surrounding the protrusionsfrom each other and the target tissue.

This device may optionally make use of active resistive heating of theentire hot plate 104, in some cases with temperature feedback providedfrom a single temperature sensor. In such cases, hot plate 104 willpreferably be thick enough so that heat transfer through the plate fromprotrusion to protrusion is sufficient so that the temperature gradientfrom one protrusion to another is negligible, allowing uniform treatmentacross the treatment surface. In alternative embodiments, protrusions106 may not be actively heated while in contact with the target tissue.Instead, hot plate 104 may be heated prior to contact with the tissue sothat heat transfer to the tissue is provided by the heat capacity of hotplate 104, as predetermined from the specific heat of the hot platematerial, the quantity of hot plate material, and the like. In fact, thedevice may be preheated in an oven or the like, so that no activeheating of the plate is provided for. Instead, the plate has sufficientheat capacity to treat the tissue if applied to the tissue for apredetermined amount of time.

In some embodiments, protrusions 106 may include resistive heatingelements such as those described above regarding FIGS. 11A-12,optionally using a combination of resistive heating and the heatcapacity of the protrusions and/or plate. Likewise, cold plate 108 mayinclude a chilled fluid conduit, thermoelectric cooling module, or thelike for actively cooling the plate, and/or may make use of the heatcapacity of the plate to passively cool the tissue through cooledprotrusions 110.

FIG. 20 illustrates an energy transmission element which isself-limiting. In this embodiment, a heat transfer surface 116(typically defined by a metal barrier) is heated by boiling an aqueousgel 118. Gel 118 is boiled by a resistive heater 120, and the steam isdirected through a nozzle 122 in an insulating material 124. The heatedsteam heats the heat transfer surface 116. Once the gel has boiled away,insulating material 124 substantially blocks the heat from resistiveheater 120 from reaching the heat transfer surface 116. Advantageously,this provides a maximum temperature determined by the boiling point ofthe aqueous gel, without requiring a temperature sensor. Furthermore,the maximum amount of heat delivered to the tissue is determined by theinitial mass of the aqueous gel provided.

FIG. 21 schematically illustrates a kit 130 including probe 20 and itsinstructions for use 132. Probe 20 may be replaced by any of the probestructure described herein, while instructions for use 132 willgenerally recite the steps for performing one or more of the abovemethods. The instructions will often be printed, optionally being atleast in-part, comprise a video tape, a CD-ROM or other machine readablecode, a graphical representation, or the like showing the above methods.

While the exemplary embodiments have been described in some detail, byway of example and for clarity of understanding, a variety ofmodifications, changes, and adaptations will be obvious to those ofskill in the art. Therefore, the scope of the present invention islimited solely by the appended claims.

What is claimed is:
 1. In a therapy for inhibiting incontinence byeffecting a desired contraction of a discrete target region within anendopelvic support tissue, a method comprising: engaging a surface of aprobe against the discrete target region of the endopelvic supporttissue; anddirecting energy from an array of transmission elementsdisposed on the probe surface into the support tissue, without movingthe probe, so as to effect the desired contraction of the target region,by transmitting the energy across a probe surface/tissue interfacehaving a length of at least 10 mm and a width of at least 5 mm, theenergy being sufficient to contract the endopelvic support tissuewithout ablating the endopelvic support tissue.
 2. The method of claim1, further comprising engaging a curving surface of the probe against anendopelvic fascia, the curving surface being at least semi-rigid.
 3. Themethod of claim 2, further comprising flexing the curving surface of theprobe against the target region so that each element of the array iselectrically coupled with the endopelvic fascia, the elements comprisingelectrodes.
 4. The method of claim 3, wherein the flexing is effected bypushing manually against a thin flat probe body.
 5. The method of claim1, further comprising engaging a semi-rigid or rigid probe surfaceagainst an endopelvic fascia.
 6. In a therapy for inhibitingincontinence by effecting a desired contraction of a discrete targetregion within an endopelvic support tissue, a method comprising:engaginga surface of a probe against the discrete target region of theendopelvic support tissue; and directing energy from a two-dimensionalarray of electrodes disposed on the probe surface into the supporttissue, without moving the probe, so as to effect the desiredcontraction of the target region, by applying bipolar electrical energybetween pairs of the electrodes, wherein at least one electrode of thearray is disposed between at least one of the pairs.
 7. In a therapy forinhibiting incontinence by effecting a desired contraction of a discretetarget region within an endopelvic support tissue, a methodcomprising:engaging a surface of a probe against the discrete targetregion of the endopelvic support tissue; directing energy from an arrayof transmission elements disposed on the probe surface into the supporttissue, without moving the probe so as to effect the desired contractionof the target region; and controlling the energy so that the supporttissue is heated to a temperature in a range from about 70° C. to about140° C. and varying a distribution of electrical power to the elementsof the array.
 8. In a therapy for inhibiting incontinence by effecting adesired contraction of a target region of an endopelvic support tissue,a method comprising:engaging a surface of a probe against a tissuesurface to provide a probe/tissue interface with a length of at least 10mm and a width of at least 5 mm; directing energy from an array ofelectrodes through the probe/tissue interface into the support tissue,without moving the probe, so as to effect the desired contraction of thetarget region; and controlling the energy by applying bipolar electricalenergy between pairs of the electrodes and by alternating the energizedelectrodes so that the bipolar energy overlaps.
 9. In a therapy forinhibiting incontinence by effecting a desired contraction of a discretetarget region within an endopelvic support tissue, a methodcomprising:engaging a surface of a probe against the discrete targetregion of the endopelvic support tissue; directing energy from atwo-dimensional array of electrodes along the probe surface into thesupport tissue, without moving the probe, so as to effect the desiredcontraction of the target region; and controlling the energy so that thesupport tissue is heated to a temperature in a range from about 70° C.to about 140° C. for a time in a range from about 0.5 to about 40seconds.